Alteplase
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ACTIVASE | — | 1995-04-03 – 2005-01-04 | fda.gov ↗ |
| Approved | US (FDA) | ACTIVASE | — | 1987-11-13 | fda.gov ↗ |
Trials 109 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06184321 | Aug 2023 → Feb 2027 expected | cancer, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 18 trials · 1 met primary | ||||||
| Phase 1 | NCT04419493 | Jun 2020 → Jun 2021 | — | Boehringer Ingelheim | Completed | Met primary |
| Phase 1 | NCT03417401 | Oct 2018 → Dec 2021 | central retinal vein occlusion | Universitaire Ziekenhuizen KU Leuven | Withdrawn | No outcome recorded |
| Phase 1 | NCT01478698 | Jan 2016 → May 2022 | — | Sir Charles Gairdner Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT02135588 | Oct 2013 → Dec 2021 | cancer | Eastern Regional Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT01591096 | Oct 2012 → Dec 2013 | stroke disorder | Seattle Children's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01581411 | Jan 2012 → Nov 2015 | central retinal vein occlusion | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 1 | NCT01150266 | Aug 2011 → Sep 2013 | ischemic stroke | University of California, San Diego | Withdrawn | No outcome recorded |
| Phase 1 | NCT00265005 | Jun 2005 → Dec 2009 | thrombotic disease | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00086723 | Jul 2003 → Jan 2006 | cancer of unknown primary site | Northwestern University | Completed | No outcome recorded |
| Phase 1/2 | NCT00250991 | Jul 2003 → Jul 2007 | stroke disorder | University of Cincinnati | Completed | No outcome recorded |
| Phase 217 trials · 2 missed | ||||||
| Phase 2 | NCT05540834 | May 2022 → May 2026 overdue | acute respiratory failure, fibrinolytic defect, thrombophilia | South West Sydney Local Health District | Recruiting | No outcome recorded |
| Phase 2 | NCT03348826 | Jun → Sep 2020 | cancer | University Health Network, Toronto | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04357730 | May 2020 → Mar 2021 | acute respiratory distress syndrome, severe acute respiratory syndrome | Denver Health and Hospital Authority | Completed | Missed primary |
| Phase 2 | NCT03854266 | Mar 2020 → Mar 2023 | pulmonary embolism | University of Aarhus | Unknown | No outcome recorded |
| Phase 2 | NCT04028518 | Jul 2019 → Oct 2020 | ischemic stroke | Angde Biotech Pharmaceutical Co., Ltd. | Unknown | Missed primary |
| Phase 2 | NCT03672006 | Apr → Dec 2019 | venous thromboembolism | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 2 | NCT04676659 | May 2018 → May 2020 | ischemic stroke | Beijing Tiantan Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02242084 | Apr 2016 → Mar 2019 | anterior spinal artery stroke, palsy, urinary bladder disorder | Rabin Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02472574 | Jun 2015 → Jun 2018 | intracerebral hemorrhage | Tongji Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01455935 | Nov 2011 → Dec 2013 | stroke disorder | Jacobs Neurological Institute | Unknown | No outcome recorded |
| Phase 2 | NCT01282242 | Jan 2011 → Jan 2016 | stroke disorder | Lee Schwamm | Completed | No outcome recorded |
| Phase 2 | NCT01183533 | Jul 2010 → Oct 2013 | ischemic stroke | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT00284739 | Feb 2006 → Oct 2007 | abscess | Kaiser Permanente | Completed | No outcome recorded |
| Phase 2 | NCT00082355 | May 2004 → Mar 2010 | venous thromboembolism | Richard Chang, M.D. | Completed | No outcome recorded |
| Phase 2 | NCT00650858 | Feb 2004 → Aug 2008 | intracerebral hemorrhage | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00132509 | Sep 2001 → Aug 2008 | stroke disorder | Hospices Civils de Lyon | Terminated | No outcome recorded |
| Phase 2 | NCT00238537 | Aug 2001 → Apr 2007 | stroke disorder | Melbourne Health | Completed | No outcome recorded |
| Phase 2/34 trials · 1 met primary · 2 missed | ||||||
| Phase 2/3 | NCT05766124 | Nov 2024 → Mar 2028 expected | respiratory tract infectious disorder | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04640194 | Dec 2020 → Jul 2022 | adult acute respiratory distress syndrome | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2/3 | NCT03876119 | Dec 2018 → May 2021 | ischemic stroke | Hospital Clinic of Barcelona | Completed | Met primary |
| Phase 2/3 | NCT01204333 | Sep 2011 → Dec 2016 | intracranial sinus thrombosis | Jan Stam, MD, PhD | Terminated | Missed primary |
| Phase 342 trials · 9 met primary · 9 missed | ||||||
| Phase 3 | NCT07668323 | Sep 2026 → Jan 2029 expected | cerebral artery occlusion, ischemic stroke | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT07727395 | Aug 2026 → Dec 2028 expected | cerebral artery occlusion, ischemic stroke | 115 People's Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT06768138 | Jun 2025 → Sep 2028 expected | ischemic stroke | Central Hospital, Nancy, France | Recruiting | No outcome recorded |
| Phase 3 | NCT06841965 | Mar 2025 → Jun 2027 expected | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06841978 | Mar 2025 → Jun 2027 expected | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06749834 | Jan 2025 → Dec 2026 expected | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 3 | NCT06352632 | Sep 2024 → Sep 2034 expected | stroke disorder | The George Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05797792 | Nov 2023 → Aug 2025 | ischemic stroke | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 3 | NCT05965687 | Aug 2023 → Aug 2024 | ischemic stroke | Ji Xunming,MD,PhD | Unknown | No outcome recorded |
| Phase 3 | NCT05856851 | Aug 2023 → Dec 2025 overdue | ischemic stroke | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | Met primary |
| Phase 3 | NCT05634382 | Dec 2022 → Nov 2024 | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 3 | NCT05429476 | Aug 2022 → Aug 2024 | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Completed | Met primary |
| Phase 3 | NCT05626972 | May 2022 → May 2023 | ischemic stroke | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 3 | NCT04430569 | Aug 2021 → Apr 2026 overdue | pulmonary embolism | Assistance Publique - Hôpitaux de Paris | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04879615 | Jun 2021 → Jun 2024 | stroke disorder | Second Affiliated Hospital, School of Medicine, Zhejiang University | Completed | Met primary |
| Phase 3 | NCT04663750 | Apr 2021 → Dec 2028 expected | wet macular degeneration | King's College Hospital NHS Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT04688320 | Dec 2020 → Jul 2023 | pulmonary embolism | Supergene, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04453371 | Oct 2020 → Jan 2021 | acute respiratory distress syndrome | Negovsky Reanimatology Research Institute | Withdrawn | No outcome recorded |
| Phase 3 | NCT04248868 | Jun 2020 → Jun 2022 | pulmonary embolism | Thrombolex, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03197194 | Jun 2018 → Jan 2024 | central retinal artery occlusion | Nantes University Hospital | Completed | Missed primary |
| Phase 3 | NCT03335839 | Apr 2018 → Sep 2024 | myocardial infarction | Population Health Research Institute | Completed | Missed primary |
| Phase 3 | NCT03187405 | Feb 2018 → Feb 2024 | acquired aneurysmal subarachnoid hemorrhage | University Hospital, Caen | Terminated | No outcome recorded |
| Phase 3 | NCT02930837 | Nov 2016 → Dec 2017 | ischemic stroke | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT02894138 | Sep 2016 → Dec 2021 | ST-elevation myocardial infarction | Vastra Gotaland Region | Unknown | No outcome recorded |
| Phase 3 | NCT02604238 | Mar 2016 | pulmonary embolism | Azienda U.S.L. 1 di Massa e Carrara | Withdrawn | No outcome recorded |
| Phase 3 | NCT02072226 | May 2014 → Mar 2017 | ischemic stroke | Genentech, Inc. | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT02002325 | May 2014 → Dec 2019 | stroke disorder | National Cerebral and Cardiovascular Center, Japan | Unknown | Missed primary |
| Phase 3 | NCT01827046 | Dec 2013 → Sep 2018 | intracerebral hemorrhage | Johns Hopkins University | Completed | Missed primary |
| Phase 3 | NCT01958164 | Sep 2013 → Apr 2014 | — | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01580839 | Dec 2012 → Aug 2018 | stroke disorder | Neuroscience Trials Australia | Completed | Met primary |
| Phase 3 | NCT01717742 | Dec 2012 → Dec 2017 | pleural empyema | The Hospital for Sick Children | Completed | Missed primary |
| Phase 3 | NCT01525290 | Sep 2012 → Oct 2018 | stroke disorder | University Medical Center Hamburg-Eppendorf | Completed | Met primary |
| Phase 3 | NCT01576679 | Mar 2012 → May 2016 | abscess | The Hospital for Sick Children | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00887328 | Jun 2010 → Aug 2018 | stroke disorder | Neuroscience Trials Australia | Completed | Met primary |
| Phase 3 | NCT00790335 | Nov 2009 → Jan 2017 | post-thrombotic syndrome, venous thromboembolism | Washington University School of Medicine | Completed | Missed primary |
| Phase 3 | NCT00784134 | Jul 2009 → Jul 2015 | intracerebral hemorrhage | Johns Hopkins University | Completed | Missed primary |
| Phase 3 | NCT00540527 | Jan 2004 → Jan 2008 | ischemic stroke | Niguarda Hospital | Completed | Missed primary |
| Phase 3 | NCT00153036 | Apr 2003 → Feb 2008 | stroke disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00147316 | Apr 2002 → Sep 2003 | brain ischemia, cerebral infarction | Tanabe Pharma Corporation | Completed | Met primary |
| Phase 3 | NCT00148460 | Mar 2001 → Feb 2006 | myocardial infarction | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00000468 | Apr 1988 → Mar 1992 | coronary artery disorder, myocardial infarction, myocardial ischemia | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT00000505 | Apr 1983 → Dec 1990 | coronary artery disorder, myocardial infarction, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 421 trials · 3 met primary · 1 missed | ||||||
| Phase 4 | NCT07816978 | Dec 2026 → Jan 2030 expected | pulmonary embolism | Sahlgrenska University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07643493 | Jul 2026 → May 2028 expected | intracerebral hemorrhage | David Dornbos | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07592520 | Apr 2026 → Apr 2027 expected | pleural empyema | Dartmouth-Hitchcock Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07095361 | Sep 2025 → Sep 2028 expected | empyema, pleural empyema, respiratory tract infectious disorder | University of North Carolina, Chapel Hill | Recruiting | No outcome recorded |
| Phase 4 | NCT06571149 | Mar 2025 → Jan 2029 expected | ischemic stroke | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 4 | NCT06115070 | Mar 2025 → Dec 2027 expected | ischemic stroke, thrombotic disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05491356 | May 2023 → Mar 2024 | fibrinolytic defect | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 4 | NCT05493163 | Oct 2022 → Mar 2026 | pulmonary embolism | Faculty Hospital Kralovske Vinohrady | Completed | No outcome recorded |
| Phase 4 | NCT04411316 | Dec 2019 → Dec 2022 | post-thrombotic syndrome, venous thromboembolism | University of Toledo Health Science Campus | Withdrawn | No outcome recorded |
| Phase 4 | NCT03988842 | Jul 2019 → Apr 2020 | acute cor pulmonale, pulmonary embolism, pulmonary embolism and infarction | Victor Tapson, MD | Terminated | No outcome recorded |
| Phase 4 | NCT03873766 | Apr 2019 → Mar 2022 | empyema, pleural empyema | Swedish Medical Center | Completed | Met primary |
| Phase 4 | NCT03581877 | Jan 2019 → Mar 2023 overdue | pulmonary embolism, pulmonary hypertension, venous thromboembolism | Northwell Health | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03740958 | Dec 2018 → Jan 2022 | ischemic stroke | General Hospital of Shenyang Military Region | Completed | Missed primary |
| Phase 4 | NCT03506009 | Jul → Nov 2018 | — | Huisheng Chen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03167281 | Feb 2017 → Mar 2021 | — | Prisma Health-Midlands | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02159521 | Jul 2014 → Nov 2017 | post-thrombotic syndrome, venous thromboembolism | Boston Scientific Corporation | Completed | Met primary |
| Phase 4 | NCT01930682 | Jan 2014 → Sep 2016 | ST-elevation myocardial infarction | RenJi Hospital | Completed | Met primary |
| Phase 4 | NCT02029456 | Jun 2011 → Mar 2014 | pulmonary embolism | Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00412867 | Dec 2006 → Jun 2008 | ischemic stroke | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 4 | NCT00303420 | Sep 2004 → Dec 2008 | thrombotic disease | University of Manitoba | Terminated | No outcome recorded |
| Phase 4 | NCT00307580 | Apr 2002 → May 2003 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase not applicable14 trials · 1 missed | ||||||
| — | NCT06433011 | Oct 2024 → Apr 2028 expected | pulmonary embolism | Thrombolex, Inc. | Recruiting | No outcome recorded |
| — | NCT06583889 | Aug 2024 → Jan 2029 expected | cerebral sinovenous thrombosis | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06487052 | Jan 2024 → Jan 2027 expected | pulmonary embolism | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | Recruiting | No outcome recorded |
| — | NCT05897554 | Aug 2023 → Mar 2025 | brain infarction, ischemic stroke, thrombotic disease | Xuanwu Hospital, Beijing | Completed | Missed primary |
| — | NCT05736757 | Dec 2022 → Apr 2023 overdue | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| — | NCT06667882 | Dec 2021 → Oct 2024 | hemorrhagic disease, pulmonary embolism | Semmelweis University | Completed | No outcome recorded |
| — | NCT04926428 | Dec 2020 → Mar 2021 | COVID-19 | Grupo Mexicano para el Estudio de la Medicina Intensiva | Completed | No outcome recorded |
| — | NCT04915586 | Dec 2019 → Dec 2020 | pleural empyema | National University of Malaysia | Completed | No outcome recorded |
| — | NCT02225782 | Oct 2014 → Jul 2016 | kidney disorder | University of Windsor | Unknown | No outcome recorded |
| — | NCT02474810 | Jan 2013 → Jul 2015 | chronic renal failure syndrome | Nova Scotia Health Authority | Completed | No outcome recorded |
| — | NCT02120066 | Jan 2011 → Jun 2013 | retinal vascular disorder | Kyorin University | Completed | No outcome recorded |
| — | NCT01141881 | May 2009 → Jan 2010 | diabetic macular edema | Mashhad University of Medical Sciences | Terminated | No outcome recorded |
| — | NCT00103766 | Oct 2004 → ? | empyema | O'Brien, Jeana D., MD, FACP, FCCP | Unknown | No outcome recorded |
| — | NCT00624000 | Mar 2004 → Sep 2007 | ischemic stroke | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Comparator or background therapy85 trials | ||||||
| Phase 0 | NCT06760195 Background | Jan → Jun 2025 overdue | ischemic stroke | Capital Medical University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06663631 Background | Nov 2024 → Jan 2025 overdue | ischemic stroke | Capital Medical University | Recruiting | No outcome recorded |
| Phase 1 | NCT05258565 Comparator | Mar → Jun 2022 | ischemic stroke | Assiut University | Completed | No outcome recorded |
| Phase 1 | NCT02492477 Background | Jan → Jul 2016 | cancer | Krankenhaus Barmherzige Schwestern Linz | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00283088 Comparator | Oct 2003 → Oct 2008 | ischemic stroke | University of California, San Diego | Completed | No outcome recorded |
| Phase 1/2 | NCT01878136 Comparator | Mar 2015 → Sep 2016 | brain aneurysm, hydrocephalus, intracranial vasospasm, subarachnoid hemorrhage | Rush University Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05281549 Comparator | May 2021 → Jan 2022 | ischemic stroke | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04110275 Comparator | Oct 2019 → May 2021 | pulmonary embolism | Angde Biotech Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04256473 Comparator | Aug 2019 → Mar 2022 | ischemic stroke | Erasmus Medical Center | Completed | Missed primary |
| Phase 2 | NCT04071613 Comparator | Jun 2019 → Nov 2021 | ischemic stroke | Melbourne Health | Completed | No outcome recorded |
| Phase 2 | NCT03108833 Comparator | Jun 2017 → Dec 2019 | pulmonary embolism | Tasly Biopharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02338466 Comparator | Jul 2016 → Jul 2018 | cerebral arterial disease | University Hospital Center of Martinique | Withdrawn | No outcome recorded |
| Phase 2 | NCT02257294 Comparator | Mar 2016 → Jul 2018 | myocardial infarction | NHS Greater Glasgow and Clyde | Completed | No outcome recorded |
| Phase 2 | NCT02388061 Comparator | Mar 2015 → Oct 2017 | ischemic stroke | Neuroscience Trials Australia | Completed | Met primary |
| Phase 2 | NCT02347358 Comparator | Feb 2015 → Jan 2017 | ischemic stroke | The Second Artillery General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01492725 Comparator | Jun 2012 → Dec 2014 | ischemic stroke | Neuroscience Trials Australia | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01472926 Comparator | Dec 2011 → Dec 2013 | ischemic stroke | NHS Greater Glasgow and Clyde | Completed | Missed primary |
| Phase 2 | NCT01464788 Background | Oct 2011 → Jun 2015 | ischemic stroke | Andrew D. Barreto, MD | Terminated | No outcome recorded |
| Phase 2 | NCT01222117 Comparator | Dec 2010 → Dec 2015 | peripheral arterial occlusive disease 1 | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT01098890 Comparator | Oct 2009 → Oct 2011 | acquired aneurysmal subarachnoid hemorrhage, intracerebral hemorrhage | University of Calgary | Unknown | No outcome recorded |
| Phase 2 | NCT00252239 Comparator | Nov 2005 → Mar 2009 | ischemic stroke | University of Virginia | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00224770 Comparator | Aug 2005 → Aug 2012 | intracerebral hemorrhage | Daniel Hanley | Completed | No outcome recorded |
| Phase 2 | NCT00044057 Background | Dec 2000 → Jan 2003 | ischemic stroke | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/3 | NCT05105633 Comparator | Nov 2021 → May 2028 expected | basilar artery occlusion | University of Melbourne | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03357133 Comparator | Dec 2017 → Jun 2020 | ischemic stroke | Capital Medical University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT02180204 Comparator | Jan 2015 → Jun 2020 | ischemic stroke | Reza Behrouz, DO | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT01123161 Comparator | Jun 2010 → Jan 2015 | ischemic stroke | University of California, San Diego | Terminated | No outcome recorded |
| Phase 2/3 | NCT00417768 Comparator | Jul 2005 → Jul 2012 | abscess | University Health Network, Toronto | Terminated | No outcome recorded |
| Phase 3 | NCT07687056 Comparator | Jun 2026 → Dec 2030 expected | ischemic stroke | University of Calgary | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06658197 Comparator | Dec 2025 → Dec 2026 expected | intracranial thrombosis, ischemic stroke | Xuanwu Hospital, Beijing | Recruiting | No outcome recorded |
| Phase 3 | NCT06878066 Comparator | Mar 2025 → Dec 2028 expected | intracerebral hemorrhage, ischemic stroke | Guri Hagberg | Recruiting | No outcome recorded |
| Phase 3 | NCT06196320 Comparator | Jan 2024 → Sep 2025 | ischemic stroke | Beijing Tiantan Hospital | Completed | Met primary |
| Phase 3 | NCT05965193 Background | Aug 2023 → Aug 2025 | ischemic stroke | Ji Xunming,MD,PhD | Unknown | No outcome recorded |
| Phase 3 | NCT05827042 Comparator | May 2023 → Jun 2026 overdue | basilar artery occlusion, stroke disorder | The First Affiliated Hospital of University of Science and Technology of China | Recruiting | No outcome recorded |
| Phase 3 | NCT05700591 Comparator | Jan 2023 → Mar 2024 | ischemic stroke | Tasly Biopharmaceuticals Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05745259 Comparator | Oct 2022 → Nov 2023 | ischemic stroke | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04965038 Comparator | Oct 2022 → Mar 2026 | central retinal artery occlusion | University Hospital Tuebingen | Terminated | No outcome recorded |
| Phase 3 | NCT05295173 Comparator | Mar 2022 → Jun 2023 | ischemic stroke | Angde Biotech Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05091320 Comparator | Dec 2021 → Nov 2022 | ischemic stroke | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT04915729 Comparator | Jun 2021 → Oct 2023 | stroke disorder | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT04797013 Comparator | Jun 2021 → May 2022 | ischemic stroke | Beijing Tiantan Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04454788 Comparator | Aug 2020 → Jul 2024 | ischemic stroke | University of Melbourne | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT03594175 Comparator | Feb 2020 → Jun 2023 | thrombotic disease, vascular occlusion disorder | Chiesi Farmaceutici S.p.A. | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT03889249 Comparator | Dec 2019 → Apr 2022 | intracranial thrombosis, ischemic stroke | University of Calgary | Completed | No outcome recorded |
| Phase 3 | NCT03854500 Comparator | Oct 2019 → Sep 2021 | ischemic stroke | Haukeland University Hospital | Terminated | No outcome recorded |
| Phase 3 | NCT04088292 Comparator | Jun 2019 → Jun 2024 overdue | pulmonary embolism | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03541668 Comparator | May 2018 → Apr 2020 | ischemic stroke | Tasly Biopharmaceuticals Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03151993 Comparator | Mar 2017 → Mar 2019 | ischemic stroke | Supergene, LLC | Completed | Met primary |
| Phase 3 | NCT02814409 Comparator | Dec 2016 → Aug 2023 | ischemic stroke | NHS Greater Glasgow and Clyde | Completed | Met primary |
| Phase 3 | NCT01862458 Comparator | Jan 2016 | empyema | Children's Mercy Hospital Kansas City | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT07146360 Comparator | May 2014 → Nov 2017 | myocardial infarction | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT01098981 Comparator | May 2013 → Apr 2015 | ischemic stroke | Cerevast Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01949948 Comparator | Sep 2012 → Dec 2016 | ischemic stroke | Lars Thomassen | Completed | No outcome recorded |
| Phase 3 | NCT00975962 Comparator | Jul 2009 → Mar 2011 | stroke disorder | Aarhus University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00640367 Comparator | Feb 2008 → Feb 2009 | stroke disorder | Niguarda Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02182011 Comparator | May 2000 → Jun 2001 | myocardial infarction | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT07111559 Comparator | Aug 2025 → Mar 2028 expected | brain small vessel disease 4, ischemic stroke | Nippon Medical School | Recruiting | No outcome recorded |
| Phase 4 | NCT05910125 Comparator | Jul 2023 → Jul 2027 expected | ischemic stroke | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06653946 Comparator | Jul 2022 → Jul 2024 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 4 | NCT06058884 Comparator | Jan 2022 → Jun 2023 | ischemic stroke | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 4 | NCT06337175 Comparator | Jun 2021 → Oct 2023 | ischemic stroke | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 4 | NCT03661411 Comparator | Oct 2018 → Jul 2022 | ischemic stroke | General Hospital of Shenyang Military Region | Completed | Met primary |
| Phase 4 | NCT03394950 Comparator | May 2018 → May 2021 | ischemic stroke | Huisheng Chen | Completed | No outcome recorded |
| Phase 4 | NCT03468933 Comparator | Nov 2017 → Dec 2019 | empyema, pleuropneumonia | Tulane University | Completed | No outcome recorded |
| Phase 4 | NCT02835534 Comparator | May 2016 → Oct 2019 | ST-elevation myocardial infarction | CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. | Completed | Met primary |
| Phase 4 | NCT02016547 Comparator | Sep 2013 → Feb 2015 | middle cerebral artery infarction | SOS Attaque Cérébrale | Terminated | No outcome recorded |
| Phase 4 | NCT02132689 Comparator | Mar 2011 → May 2015 | pulmonary embolism | University Hospital Ostrava | Completed | No outcome recorded |
| Phase 4 | NCT01956955 Comparator | Jan 2011 → Dec 2013 | — | Ataturk University | Unknown | No outcome recorded |
| Phase 4 | NCT01246453 Comparator | Dec 2003 → Dec 2010 | pleural empyema | Hospital Universitari Vall d'Hebron Research Institute | Completed | No outcome recorded |
| — | NCT06833827 Comparator | Feb 2025 → Jan 2028 expected | pulmonary embolism | Leiden University Medical Center | Recruiting | No outcome recorded |
| — | NCT07360717 Comparator | Nov 2024 → Dec 2025 | — | U. N. Mehta Institute of Cardiology and Research Center | Completed | No outcome recorded |
| — | NCT06241677 Comparator | Apr 2024 → Dec 2028 expected | ischemic stroke | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| — | NCT05903417 Comparator | Jul 2023 → Oct 2025 | respiratory tract infectious disorder | National University of Malaysia | Completed | No outcome recorded |
| — | NCT05631847 Comparator | Apr 2023 → Aug 2025 | basilar artery occlusion, ischemic stroke, thrombotic disease | Sichuan Academy of Medical Sciences | Completed | No outcome recorded |
| — | NCT03392792 Comparator | Dec 2018 | — | Assiut University | Unknown | No outcome recorded |
| — | NCT03583931 Comparator | Jul 2018 → Feb 2020 | blood coagulation disease, pleural empyema, pleuropneumonia | Denver Health and Hospital Authority | Completed | No outcome recorded |
| — | NCT03469206 Comparator | Feb 2018 → Oct 2019 | cerebral artery occlusion, ischemic stroke, thrombotic disease | Changhai Hospital | Completed | No outcome recorded |
| — | NCT03192332 Comparator | Nov 2017 → May 2021 | ischemic stroke | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| — | NCT02216565 Background | Dec 2014 → Aug 2015 | ischemic stroke | Fondation Ophtalmologique Adolphe de Rothschild | Terminated | No outcome recorded |
| — | NCT02326428 Background | Mar 2014 → Jan 2018 | ischemic stroke | Karolinska Institutet | Completed | No outcome recorded |
| — | NCT01745692 Background | Dec 2012 → Apr 2015 | ischemic stroke | NHS Greater Glasgow and Clyde | Terminated | No outcome recorded |
| — | NCT01062698 Comparator | Jun 2010 → Dec 2015 | ischemic stroke | Central Hospital, Nancy, France | Terminated | No outcome recorded |
| — | NCT01197573 Comparator | Apr 2010 → Oct 2015 | — | The Cleveland Clinic | Completed | No outcome recorded |
| — | NCT00468104 Comparator | Apr 2004 → Oct 2008 | pleural disorder | Midwest Pulmonary and Critical Care | Completed | No outcome recorded |
| — | NCT01451320 Comparator | Jan 1993 → Dec 2009 | — | Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2017-09-06 | Genentech, Inc. | Regulatory Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection gene.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-02-05 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - INDICATION FOR ACUTE ISCHEMIC STROKE OF MINGFULE (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIVATOR FOR INJECTION) OBTAINS MARKETING APPROVAL irasia.com ↗ |
| 2022-11-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF NEW INDICATION APPLICATION FOR MARKETING APPROVAL OF MINGFULE (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIVATOR FOR INJECTION) irasia.com ↗ |
| 2022-08-04 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - MINGFULE (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIVATOR FOR INJECTION) MET PRIMARY ENDPOINT IN PHASE III STUDY FOR THE TREATMENT OF ACUTE ISCHEMIC STROKE irasia.com ↗ |
| 2017-09-06 | Genentech, Inc. | Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection gene.com ↗ |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 203 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alteplase | “We randomly assigned patients with ischemic stroke who were receiving 0.9 mg of alteplase per kilogram of body weight less than 4.5 hours after the onset of ischemic stroke...” PMID 25671797 ↗ Feb 2015138“Patients were randomized within 3 h of onset to receive either intravenous alteplase, in accordance with the current European labeling, or up to 0.9 mg/kg intra-arterial...” PMID 21990564 ↗ Oct 2009 “We included patients with acute ischaemic stroke (National Institutes of Health Stroke Scale score ≥10) who received intravenous thrombolysis (alteplase bolus) within 3 h of...” PMID 30878103 ↗ Apr 2019 “After each catheter placement, subsequent bolus of 1mg of Alteplase (Actilyse, Boehringer Ingelheim)/catheter is administered, followed by continuous infusion at 1...” NCT05493163 ↗ “Standard reperfusion treatment for high-risk PE patients is thrombolytic therapy, typically consisting of Alteplase, Urokinase, or Tenecteplase, with the idea of accelerated...” NCT06833827 ↗ “In the combined treatment group, intravenous alteplase (0·9 mg/kg bodyweight, maximum dose 90 mg per patient) was administered as early as possible after randomisation for 60...” PMID 35810756 ↗ Jul 2022 “Targeted, intracoronary delivery of low-dose recombinant tissue plasminogen activator (alteplase) might be an effective strategy for improving microvascular obstruction without...” PMID 41194755 ↗ Oct 2025 “Standard endovascular techniques to mechanically remove clot material, such as mechanical thrombectomy and/or balloon angioplasty and/or local application of alteplase or...” NCT06583889 ↗ “Recombinant human tissue-type plasminogen activator(rt-PA,chemical name:Alteplase,brand name: Actilyse)50mg/stick,provided by Boehringer Ingelheim Pharma Gesellschaft mit...” NCT04110275 ↗ “Patients randomized to the IPFT study arm will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg BID x 3 days delivered through a chest tube or small bore catheter...” NCT03873766 ↗ “Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low...” NCT00132509 ↗ |
| Known as | Actilyse | “After each catheter placement, subsequent bolus of 1mg of Alteplase (Actilyse, Boehringer Ingelheim)/catheter is administered, followed by continuous infusion at 1...” NCT05493163 ↗9“Alteplase is a recombinant tissue plasminogen activator used for thrombolytic treatment in several indications and is currently approved in Europe under the brand name Actilyse®.” PMID 37248330 ↗ May 2023 “Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).” NCT03417401 ↗ “Intravenous thrombolysis by alteplase (Actilyse) (optional)” NCT02326428 ↗ “Alteplase (rt-PA)/Actilyse” NCT01062698 ↗ |
| Known as | Activase | “administration of recombinant tissue plasminogen activator or Activase (Alteplase, rt-PA), which promotes the proteolytic action of plasmin from plasminogen at the site of a clot.” NCT00624000 ↗ |
| Known as | Actylise | “All the patients will be given a 15 minutes IA infusion of alteplase (Actylise®) at a drug concentration of 1.0 mg/ml.” NCT03876119 ↗1“All the patients will be given a 15 minutes IA infusion of alteplase (Actylise®) at a drug concentration of 1.0 mg/ml.” NCT05797792 ↗ |
| Known as | ALP | “both drugs (Alteplase (ALP) and Tenecteplase (TNK)) are approved drugs for the indication AIS with similar efficacy and safety profile.” NCT06878066 ↗ |
| Known as | Alteplase for Injection | “Active Comparator: Alteplase Drug: Alteplase for Injection Dose:50mg;20mg” NCT04028518 ↗ |
| Known as | Alteplase injection (rt-PA) | “Alteplase injection (rt-PA)” NCT04797013 ↗ |
| Known as | Cathflo | “Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and prevent clotting of the catheter during HD...” NCT02474810 ↗1“Cathflo (Alteplase)” NCT01576679 ↗ |
| Known as | Cathflo Activase | “Cathflo Activase (Alteplase)” NCT00307580 ↗ |
| Known as | recombinant t-PA | “activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)” NCT00250991 ↗ |
| Known as | recombinant tissue plasminogen activator | “administration of recombinant tissue plasminogen activator or Activase (Alteplase, rt-PA), which promotes the proteolytic action of plasmin from plasminogen at the site of a clot.” NCT00624000 ↗2“activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)” NCT00250991 ↗ “low-dose recombinant tissue plasminogen activator (rtPA, or alteplase)” NCT00082355 ↗ |
| Known as | recombinant tissue-type plasminogen activator | “Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA,alteplase) or TNK-tPA (Tenecteplase,Metalyse)” NCT05634382 ↗1“intravenous recombinant tissue-type plasminogen activator (rt-PA) versus intravenous streptokinase” NCT00000505 ↗ |
| Known as | rtPA | “An Open Label, Multicenter, Single-arm Trial to Assess Safety and Efficacy of Alteplase (Rt-PA) in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is...” NCT02930837 ↗35“Recombinant human tissue-type plasminogen activator(rt-PA,chemical name:Alteplase,brand name: Actilyse)50mg/stick,provided by Boehringer Ingelheim Pharma Gesellschaft mit...” NCT04110275 ↗ “Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low...” NCT00132509 ↗ “Previous studies on high-dose, short-term thrombolysis with alteplase (rtPA) showed a reduced risk of hemodynamic deterioration but no change in mortality and increased...” PMID 39732696 ↗ Dec 2024 “administration of recombinant tissue plasminogen activator or Activase (Alteplase, rt-PA), which promotes the proteolytic action of plasmin from plasminogen at the site of a clot.” NCT00624000 ↗ “All patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion” NCT06760195 ↗ “Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA,alteplase) or TNK-tPA (Tenecteplase,Metalyse)” NCT05634382 ↗ “Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset.” NCT02016547 ↗ “intravenous recombinant tissue-type plasminogen activator (rt-PA) versus intravenous streptokinase” NCT00000505 ↗ “rhPro-UK vs. alteplase (recombinant tissue plasminogen activator [rt-PA]) in patients with aPE.” PMID 41916317 ↗ Mar 2026 “To collect additional confirmatory data on alteplase(rt-PA) in the European setting” NCT00153036 ↗ |
| Known as | t-PA | “instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic...” NCT03468933 ↗22“A follow-up trial using the widely available tissue-type plasminogen activator (t-PA) alteplase is now needed to assess optimal dosing and safety in this critically ill patient...” PMID 32838109 ↗ Aug 2020 “10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily with initial administration occurring at chest tube placement.” NCT03167281 ↗ “After chest tube insertion, participants in the treatment group will receive intrapleurally administered tissue plasminogen activator (tPA) 4 mg followed by dornase alfa 5 mg.” PMID 28646887 ↗ Jun 2017 “Tissue Plasminogen Activator (tPA) is infused through the ClearRRAflow catheter into the ventricular system to promote clearance of intraventricular hemorrhage.” NCT07643493 ↗ “Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).” NCT01141881 ↗ “tissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.” NCT07095361 ↗ “The TIMI trial of tissue plasminogen activator (TPA), which is more clot-specific than streptokinase, has substantiated the effectiveness.” NCT00000468 ↗ “DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses” NCT03583931 ↗ “Patients receive tissue plasminogen activator (tPA) IV over 6 hours and oral captopril twice daily on days 1-5.” NCT00086723 ↗ “intrapleural 10 mg alteplase (t-PA) with 5 mg of pulmozyme (DNase) twice daily for 72 h were used.” PMID 35581627 ↗ May 2022 |
| Known as | tissue plasminogen activator | “Targeted, intracoronary delivery of low-dose recombinant tissue plasminogen activator (alteplase) might be an effective strategy for improving microvascular obstruction without...” PMID 41194755 ↗ Oct 202532“Complex pleural space infections often require treatment with multiple doses of intrapleural tissue plasminogen activator (tPA) and deoxyribonuclease, with treatment failure...” PMID 38710463 ↗ May 2024 “instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic...” NCT03468933 ↗ “After chest tube insertion, participants in the treatment group will receive intrapleurally administered tissue plasminogen activator (tPA) 4 mg followed by dornase alfa 5 mg.” PMID 28646887 ↗ Jun 2017 “BACKGROUND: Whether intravenous tissue plasminogen activator (alteplase) is effective beyond 3 h after onset of acute ischaemic stroke is unclear.” PMID 18296121 ↗ Feb 2008 “tissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.” NCT07095361 ↗ “tissue plasminogen activator (tPA)-a naturally occurring protein that opens blocked arteries by dissolving blood clots” NCT01123161 ↗ “Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid.” NCT03167281 ↗ “Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema” NCT01862458 ↗ “recombinant tissue plasminogen activator (rtPA)” PMID 31069128 ↗ Apr 2019 |
| Known as | tissue plasminogen activator (tPA) | “tissue plasminogen activator (tPA)” NCT01222117 ↗ |
| Known as | tissue-type plasminogen activator | “A follow-up trial using the widely available tissue-type plasminogen activator (t-PA) alteplase is now needed to assess optimal dosing and safety in this critically ill patient...” PMID 32838109 ↗ Aug 2020 |
| Action | Activate | “promotes the proteolytic action of plasmin from plasminogen at the site of a clot” NCT00624000 ↗ |
| Modality | Protein / enzyme biologic | “recombinant tissue-type plasminogen activator (rt-PA)” NCT00000505 ↗ |
| Route | Intravenous | “intravenous rt-PA” NCT00000505 ↗ |